BEUDAMED
    FDA Recall Terminated

    1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation

    Recall: Z-1947-2013 · Initiated April 22, 2013

    Recall

    Recall Number
    Z-1947-2013
    Event Number
    64971
    Firm
    Carefusion 2200 Inc 1500 S Waukegan Rd Mpwm Bldg. Waukegan IL 60085-6728
    FEI Number
    3008002452
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 22, 2013
    Posted
    August 13, 2013
    Terminated
    June 16, 2015

    Description

    1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation

    Reason

    CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk.

    Action

    CareFusion sent an URGENT RECALL NOTICE letter dated April 22, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to complete and return an attached Distributor Acknowledgement Form within fifteen (15) days of receipt indicating their acknowledgement of the URGENT RECALL NOTICE and indicate if they have any affected product on hand. They are further requested to perform a 100% physical inventory to verify if any of the affected product codes/lot numbers are in stock within their distribution network/facility. In addition, customers are requested to forward the Customer Acknowledgement Form, the Customer Notification Letter, the Certificate of Destruction Form, the Pictures of Location of Lot Numbers on Case/Product, and the Frequently Asked Questions (FAQs) to all end users which they have distributed the affected product. For questions call 847-473-7097.

    Distribution

    US Nationwide in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, WA

    Quantity

    14,112 units